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Regulatory Affairs Specialist

São Paulo, Brazil Req ID JR-041007
Scientists wearing lab coats

Revvity | About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity.

• Prepare draft dossiers for product registrations with regulatory authorities for Revvity Brasil .
• Maintain and organize the Master Repository of records for Brazil and Mexico.
• Keep the Smart Sheet(s) up to date as directed by the manager.
• Communicate with the GTS team regarding new registrations and revalidations in LATAM, ensuring that the GTS is updated and accurate according to the information provided.
• Assist in ANVISA Good Distribution and Storage Practices at the company’s branch site in Barueri, where presence is required 1 to 2 times per week to:
    o Conduct audits of incoming and outgoing goods
    o Implement SOPs with the 3PL
    o Support the Quality Manager in audits with the 3PL
    o Open incidents and monitor 3PL responses
    o Track 3PL SLAs

• Keep regulatory files organized as directed by the manager.
• Follow all Revvity Inc. policies and LATAM QMS procedures related to your tasks.
• Act proactively by bringing solutions to problems and continuously improving activities.
• Work routinely but always follow the described processes, and in case of doubts, proactively seek guidance from the manager

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